Status Approved
First Submitted Date
2020/03/17
Registered Date
2020/05/21
Last Updated Date
2020/05/04
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005048 |
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Unique Protocol ID | DGIRB-2019-12-001 |
Public/Brief Title | Single-incision Versus Conventional Laparoscopic Appendectomy |
Scientific Title | Multi-Center Prospective Study to Compare Single-incision Versus Conventional Laparoscopic Appendectomy |
Acronym | SCAR |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | DGIRB-2019-12-001-001 |
Approval Date | 2020-02-27 |
Institutional Review Board Name | Daegu Joint institutional Review Board |
Institutional Review Board Address | Room# 316, Kyungpook National University School of Medicine, 680 Gukchaebosang-ro, Jung-gu, Daegu, Republic of Korea 41944 |
Institutional Review Board Telephone | 053-623-8490 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Sung Uk Bae |
Title | Assistant professor |
Telephone | +82-53-258-7884 |
Affiliation | Keimyung University Dongsan Hospital |
Address | 1095 Dalgubeol-daero, Dalseo-gu |
Contact Person for Public Queries | |
Name | Sung Uk Bae |
Title | Assistant professor |
Telephone | +82-53-258-7884 |
Affiliation | Keimyung University Dongsan Hospital |
Address | 1095 Dalgubeol-daero, Dalseo-gu |
Contact Person for Updating Information | |
Name | Sung Uk Bae |
Title | Assistant professor |
Telephone | +82-53-258-7884 |
Affiliation | Keimyung University Dongsan Hospital |
Address | 1095 Dalgubeol-daero, Dalseo-gu |
4. Status
Study Site | Multi-center Number of center : 3 | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-06-01 Anticipated | |
Target Number of Participant | 120 | |
Primary Completion Date | 2021-06-30 , Anticipated | |
Study Completion Date | 2021-07-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Keimyung University Dongsan Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-06-01 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Yeongnam University Medical Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-06-01 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | Daegu Catholic University Medical Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-06-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | DALIM MEDICAL CORPORATION |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Keimyung University Dongsan Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | As minimally invasive surgery has rapidly developed in recent years, minimizing surgical trauma and improving cosmetic outcomes, single-port laparoscopic surgery was introduced. The aim of our study is to compare outcomes between single-port and multi-port laparoscopic appendectomy for acute appendicitis and to evaluate the feasibility of single-port laparoscopic appendectomy as a standard procedure. After obtaining the consent of the study, inclusion and exclusion criteria are checked, and a single-port laparoscopic surgery and a traditional multi-port laparoscopic surgery are determined by randomly assigning a method. 1) Baseline demographics of each participants such as age, height, body weight, preoperative white blood cell count and C-reactive protein level etc. will be obtained before surgery. 2) Intraoperative findings (e.g. operative time, conversion to open or conventional multi-port laparoscopic surgery, vascular or organ injury during trocar insertion, incision length will be recorded. 3) Visual Analog Scale will be obtained at 6 hours after end of surgery, postoperative day 1 and 2 in the morning. 4) International Pain Outcomes questionnaire will be obtained at postoperative day one. 5) Patient and observer scar assessment scale and body image questionnaires will be obtained 6 weeks after surgery in the outpatient clinic. If the participant were not visit the day, telephone interview will be permit for completion of the survey. 6) Postoperative outcomes including hospital stay, complication, re-admission within 30 days after operation will be also collected. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-control |
Time Perspective | Prospective |
Target Number of Participant | 120 |
Cohort/Group Number | 2 |
Cohort/ Group 1 |
Cohort/Group Label Single-port laparoscopic group |
Cohort/Group Description For the group who undergo a single-port laparoscopic appendectomy via single incision at umbilical area, the surgical results, postoperative complications, and short-term clinical outcomes after surgery are observed. |
|
Cohort/ Group 2 |
Cohort/Group Label Conventional laparoscopic group |
Cohort/Group Description For the group who undergo a multi-port laparoscopic appendectomy via 3-port trocar insertion at peri-umbilical, left lower quadrant and supra-pubic site, the surgical results, postoperative complications, and short-term clinical outcomes after surgery are observed. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients ≤75 years diagnosed acute appendicitis who will receive laparoscopic appendectomy |
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Sampling Method | The target sample size will be 120 participants by probability sampling, as this will provide 80% power at the 2.5% (2-sided) level of significance to detect a 3-points differences in Patient and Observer Scar Assessment (POSA) score at 6 weeks after surgery between the SILA group and the control group, with allowance for 10% attrition. |
Condition(s)/Problem(s) |
* (K00-K93)Diseases of the digestive system (K35.8)Acute appendicitis, other and unspecified Appendicitis, Appendectomy, Laparoscopy, Wounds and Injuries, Pain |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~75Year |
|
Description 1) Patients aged ≥19 and ≤75 years 2) Patients diagnosed acute appendicitis who will receive laparoscopic appendectomy |
|
Exclusion Criteria |
1) patients who is suspected perforated appendicitis 2) patients with pan-peritonitis symptom 3) patients who has previous major abdominal surgery except cholecystectomy, Cesarean delivery 4) patients who have an inability to express himself/herself due to conditions such as dementia and intellectual disabilities 5) patients who have chronic pain need to take analgesics 6) pregnancy 7) patients diagnosed as other disease 8) patients who have severe medical disease such as pulmonary, cardiovascular, hepatic, or renal insufficiency |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Patient and Observer Scar Assessment |
|
Timepoint | 6 weeks after surgery |
|
Secondary Outcome(s) 1 | ||
Outcome | international Pain Outcomes questionnaire |
|
Timepoint | postoperative day 1 |
|
Secondary Outcome(s) 2 | ||
Outcome | Visual Analogue Scale |
|
Timepoint | 6 hours after end of surgery, postoperative day 1 and 2 |
|
Secondary Outcome(s) 3 | ||
Outcome | Body image Questionnaire |
|
Timepoint | 6 weeks after surgery |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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